Kornimate/medical-research-clean huggingface dataset:
combination of sotyktu and enstilar for plaque psoriasis

Conditions: Psoriasis

Summary: combination deucravacitinib and enstilar foam

30 adult patients with moderate to severe plaque psoriasis will be given deucravacitinib 6mg qd for the first 8 weeks of the study. at week 8: subjects who do not meet pasi 25 at week 8 will be discontinued from the study as non-responders. subjects who achieve ≥pasi 75 at week 8 will remain enrolled and continue deucravacitinib 6mg qd monotherapy through week 24. subjects who achieved between pasi 25-74 response will receive 4 weeks of enstilar (calcipotriene and betamethasone dipropionate) foam, 0.005%/0.064% applied qd in addition to continuing deucravacitinib 6mg qd. at week 12, (after 4 consecutive weeks of enstilar), subjects in the pasi 25-74 group, will discontinue enstilar qd and continue deucravacitinib as monotherapy through week 24. subjects will return at week 28 for safety follow evaluation.

Eligibility criteria:
inclusion criteria: 1. male or female adult ≥ 18 years of age; 2. diagnosis of chronic plaque-type psoriasis 3. moderate to severe plaque type psoriasis as defined at baseline by: * bsa affected by plaque-type psoriasis of 10% or greater * pga score of 3 or greater * pasi ≥ 12. 4. able and willing to give written informed consent prior to performance of any study-related procedures must be in general good health (except for disease under study) as judged by the investigator, based on medical history, physical examination, clinical laboratories, and urinalysis. exclusion criteria: 1. other than psoriasis, any clinically significant (as determined by the investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major disease that is uncontrolled. 2. forms of psoriasis other than chronic plaque-type (e.g., pustular erythrodermic and/or guttate psoriasis) or drug induced psoriasis 3. use of oral systemic medications or puva phototherapy for the treatment of psoriasis within 4 weeks (includes, but not limited to, oral corticosteroids, methotrexate, acitretin and cyclosporine). 4. prior use of biologics within the following periods: * etanercept - 4 weeks * adalimumab or certolizumab pegol - 8 weeks * il-17 antagonists - 16 weeks * ustekinumab or il-23 pathway inhibitors - 24 weeks * other biologics - 5 half-lives 5. patient used topical therapies or uvb phototherapy to treat psoriasis within 2 weeks of the baseline visit (includes, but not limited to, topical corticosteroids, vitamin d analogs, or retinoids).
prevention of syncope by cardiac pacing in patients with bifascicular block

Conditions: Bifascicular Block; Syncope

Summary: study objective the purpose of this study is to evaluate the efficacy of bradycardia pacing with respect to patient symptoms in patients with bifascicular block and syncope of unexplained origin.

primary endpoint first occurrence of a composite of syncope of any origin or presyncopal episode with documented cardioinhibitory origin or atrioventricular block of any degree; all associated with patient symptoms design: * randomized, prospective, single blinded, two parallel arms * treatment group : ddd60 - programmed in ddd mode / 60 lower limit * control group: ddi30 - programmed in ddi mode / 30 lower limit * randomization type: block randomization: block size: 4, allocation ratio 1:1 sample: 100 patients population * patients with bifascicular block with at least one syncopal episode within the last 6 months preceding enrollment. * patients should be negative to a series of pre-enrollment screening in order to exclude: * brady-tachy syndrome, vasovagal syncope or carotid sinus syndrome, atrial fibrillation, inducible av block * ejection fraction \>=40% * mean nocturnal heart rate \>=35 bpm

Eligibility criteria:
inclusion criteria: * evidence of bifascicular block * at least one episode of syncope during last 6 months from the enrollment exclusion criteria: * patients with brady-tachy syndrome that needs of pacemaker to prevent the symptomatic bradycardia o symptomatic tachycardia arrhythmia * patients with vasovagal syndrome by positive ttt or carotid sinus syndrome * patients with chronic atrial fibrillation * patients with atrial ventricular block induces at eps

Keywords: syncope bifascicular block bradycardia pacing
early postoperative blood glucose variability and outcome after tavi

Conditions: Stress Hyperglycemia

Summary: stress hyperglycaemia is a well-known risk factor of postoperative morbidity and mortality in cardiac surgery. recently, several authors have reported that increased blood glucose (bg) variability could worsen the prognosis in this population.the transcatheter aortic valve implantation (tavi) is a low invasive procedure proposed as an alternative technique to aortic valve replacement surgery in high-risk patients. the aim of this study is to describe the incidence of stress hyperglycaemia and assess whether bg variability could impact the outcome of patients undergoing tavi.


Eligibility criteria:
inclusion criteria: * age\>18 years old * severe degenerative symptomatic aortic stenosis * logistic euroscore ≥ 20% or/and society of thoracic surgeons score (sts) ≥ 10% * recused for a conventional valve replacement by multidisciplinary team (surgeon, cardiologist) because of surgical contraindication or comorbidities related to the patient. * written consent before the procedure concerning anonymous data processing. exclusion criteria: * death per procedure * postoperative admission in a critical care unit

Keywords: aortic valve replacement percutaneous valve blood glucose variability tavi
safety and efficacy of allogeneic nk cells therapy in patients with advanced hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: this is a multicenter, open-label, paired control study to evaluate the safety and clinical efficacy of allogeneic nk cells combined with targeted drug in the treatment for advanced hcc.

since killer cell immunoglobulin-like receptor (kir) mismatch can inhibit the negative regulatory signal of autologous major histocompatibility complex (mhc) molecules and ensure sufficient nk cell activation, allogeneic nk cells therapy, as a potential therapeutic option for tumor, has achieved good results in patients with acute myeloid leukemia. in this study, investigators evaluate the safety and efficacy of allogeneic nk cells in the treatment of advanced hcc. 200 patients from three hospitals will be enrolled in this study and followed up for 1 year. peripheral blood mononuclear cells (pbmcs) were isolated from patient-related donor and cultured in vitro for 15 days and infused to the patient in two consecutive days. clinical data and laboratory data were collected and analyzed, including survival, impact indicators, hematology, biochemical indicators, and immunological indicators to evaluate the safety and efficacy of the treatment.

Eligibility criteria:
inclusion criteria: * according to the 2010 edition of the diagnostic criteria for primary liver cancer bclc, the patient was diagnosed as advanced hepatocellular carcinoma by pathology and imaging (bclc c phase); * child-pugh a/b (5-9), eastern cooperative oncology group (ecog) ps score less than 2 points; * laboratory criteria: 1. liver function: child a/b, alt \< 200 u/l, ast \< 200 u/l, tbil \<51μmol/l 2. renal function: creatinine clearance ≥ 60ml/minute 3. hematologic function: plt ≥40×10'9/l, wbc ≥2×10'9/l, hgb\>80 g/l 4. cardiac function: no abnormality in cardiac enzyme and ecg * survival expectation is greater than 6 months; * patients with active hepatitis b or c were treated with the appropriate na or daa medication, and all patients enrolled in the group were treated with targeted drugs. * the patient has a donor who meets the donor enrollment criteria and all patients and donors sign the informed consent form; exclusion criteria: * women who are pregnant or breast-feeding. * co-infected with hepatitis a, hepatitis e, aids or other infectious diseases. * patients with serious complications such as acute infection and gastrointestinal bleeding within 30 days. * patients with other serious systemic and psychiatric diseases. * exposure to any cell therapy such as, but not limited to cik, dc, ctl , pd-1 and stem cells therapy 6 months prior to study drug administration. * other conditions that researchers believe may increase the risk of subjects or lead to affected study results, such as the presence of mental illness in subjects.
lesional evaluation of high risk patients with neoatherosclerosis treated with rosuvastatin and eicosapentaenoic acid using optical coherence tomography(oct)[link it two]

Conditions: Coronary Artery Disease; Angina Pectoris

Summary: this study aim is to evaluate the additional effect of eicosapentaenoic acid and dose up effect of rosuvastatin for neoatherosclerosis in coronary artery disease patients.

eicosapentaenoic acid and statin therapy prevents cardiovascular events. however, the impact of these treatment in patients with in-stent neoatherosclerosis has not been clarified. so, the investigators conducted link it study. this study showed that eicosapentaenoic acid(epa) and rosuvastatin therapy improve lipid index in patients compared with rosuvastatin alone therapy. however, it was insufficient to directly evaluate the efficacy of additional effect of epa for neoatherosclerosis. because, statin dose of two groups was different and type of stent was variety. therefore, the investigators designed a new prospective, randomized oct study. the oct operators randomly assigned 75 patients who were detected neoatherosclerosis on follow-up oct examination after implanted everolimus eluting stent to three groups; 5mg/day of rosuvastatin therapy (low dose statin therapy group) or 10mg/day of rosuvastatin therapy (high dose statin therapy group) or 10mg/day of rosuvastatin and 1800mg/day of eicosapentaenoic acid therapy (epa and statin therapy group). serial coronary angiography and oct were performed at 9 months after baseline oct procedure. this study aim is to evaluate the additional effect of eicosapentaenoic acid and dose up effect of rosuvastatin for neoatherosclerosis in coronary artery disease patients by comparing 3 groups.

Eligibility criteria:
inclusion criteria: 1. over 20 years 2. patients implanted everolimus-eluting stent(ees) neoatherosccrelosis with neoatherosclerosis by oct 3. ldl is or less than 100 mg/dl after ingesting 5 mg/day of rosuvastatin exclusion criteria: 1. patients taking omega 3 fatty acid before randomization 2. patients allergic to rosuvastatin or eicosapentaenoic acid 3. patients with a history of hemorrhagic stroke 4. patients taking anti cancer agent 5. patients undergoing ldl apheresis 6. patients with severe liver disease or severe kidney disease 7. patients who conflict with any of the warnings or contraindications listed in the domestic package insert of rosuvastatin 8. patients who conflict with any of the warnings or contraindications listed in the domestic package insert of eicosapentaenoic acid 9. patients performed percutaneous coronary intervention with restenosis of target lesion 10. pregnant women or patients with possibility of pregnancy or nursing woman

Keywords: eicosapentaenoic acid oct neoatherosclerosis
a non-interventional national study in pediatric patients with unexplained enlarged spleen

Conditions: Gaucher Disease, Splenomegaly; Acid SphingoMyelinase Deficiency

Summary: primary objective: to assess prevalence of gaucher disease (gd) diagnosed in pediatric patients presenting with unexplained splenomegaly (smg) after exclusion of first intention-diagnoses (e.g. portal hypertension, haematological malignancy, hemolytic anemia, infection) based on clinical examination and routine biological tests (full blood count, reticulocytes, liver tests, abdominal ultrasound, coombs test and epstein barr virus serology). secondary objectives: * to describe the rate of each identified disease category and the rate of patients with no final diagnosis at the end of the study in pediatric patients with unexplained smg after exclusion of first intention diagnoses * to describe the characteristics (clinical, lab, genetics) of all pediatric patients included in the study and to describe the characteristics subdivided by identified disease category and absence of final diagnosis at the end of the study

the planned duration of this study is 39 months, which includes 36 months of patient recruitment.

Eligibility criteria:
inclusion criteria: * patient under the age of 18 years * patient with unexplained smg (smg defined as a palpable spleen, already known or discovered for the first time) and who has undergone tests to eliminate obvious causes of smg exclusion criteria: patient with any obvious cause of smg as described by clinical examination and/or lab or imaging test available in medical records and/or having been diagnosed with any of the following conditions: 1. hemolytic anemia 2. hematological malignancy 3. portal hypertension 4. infectious disease associated with smg (cytomegalovirus, epstein barr virus, leishmaniasis or other obvious infectious cause revealed by the medical history) the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
mechanisms of upper-extremity motor recovery in post-stroke hemiparesis

Conditions: Cerebrovascular Accident

Summary: the results of this study will provide sound, scientific evidence of physiologic mechanisms responsible for upper-extremity weakness; evidence of the processes involved in neuromuscular adaptation; and will elucidate the relationship between impairment and motor disability in post-stroke hemiparesis.

this proposal extends the work accomplished in our initial study (project #b2405r, 'effects of strength training on upper-limb function in post-stroke hemiparesis'). in the present study we will conduct a double-blind, randomized clinical trial of staged rehabilitation for the upper-extremity involving sequential delivery of functional therapy and high intensity resistance training. therefore, this proposal directly compares the effects of functional and resistance training delivered individually. the researchers' previous work investigated a hybrid therapy of functional and resistance training against functional training alone. all subjects will participate in a 5 week run-in period of no treatment. this no-treatment block will afford multiple baseline measurements and, in addition, will provide information regarding the rate and magnitude of any spontaneous recovery without treatment. following the second baseline measurement, all subjects will be randomized to upper-extremity rehabilitation in either: order a - 10 weeks of functional task practice training (ftp) followed by 10 weeks of high-intensity resistance training (power) or order b - resistance training (power) followed by ftp. re-evaluation will occur following each block of treatment,and retention effects will be evaluated after 6 and 12 months with no additional treatment. subjects will be evaluated with: outcome measures used broadly in clinical neurology and rehabilitation, a battery of biomechanical performance measures including: strength, muscle activation, reflex modulation, and motor coordination, and with kinematics of free reaching movements. the researchers will investigate persons in the intermediate phase of recovery which they define as between 6 and 18 months post-stroke , having completed all inpatient and outpatient therapies, with remaining residual motor deficits.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of cerebrovascular accident * single event * unilateral hemiplegia * between 6 months and 18 months post-event * impairment of upper-extremity function * ability to produce partial range of motion out of plane of gravity at shoulder, elbow, and wrist * at least 10 degrees of wrist motion (any 10 degrees), and finger flexion/extension in 2 fingers * cognitive ability to follow 3-step commands exclusion criteria: * unstable or uncontrolled blood pressure * uncontrolled seizures * flaccid hemiplegia * severe cognitive impairment

Keywords: biomechanics cerebrovascular accident electromyography muscular weakness recovery of function reflex variability stroke upper-extremity kinematics
inspiratory muscle training and nasal high flow in difficult weaning

Conditions: High-risk for Reintubation Patients; Weaning Outcome

Summary: the purpose of the present study is to investigate the effectiveness of inspiratory muscle training and nasal high flow oxygen in patients with difficult weaning and high-risk for re-intubation. the hypothesis of the study is that starting inspiratory muscle training once patients are awake and co-operative along with the application of nasal high flow oxygen immediately after extubation will have a beneficial effect in preventive re-intubation in these high-risk patients.

20-30% of intubated patients are difficult to be weaned off the mechanical ventilation and have a prolonged icu stay. it is well established that prolonged icu stay is associated with reduced muscle strength, functional ability and quality of life. inspiratory muscle training (imt) via a threshold device has been proposed as an effective exercise for minimizing the detrimental effect of mechanical ventilation in critical ill patients with prolonged weaning. additionally, nasal high flow (nhf) oxygen has been proved to support efficiently either high or low-risk patients after extubation and thus preventing re-intubation. a randomized intervention study was designed to assess the efficacy of combining imt and nhf as therapeutic strategies for difficult weaning. once patients with prognostic factors of difficult weaning are awake and co-operative they will be randomized to one of the two following study groups: 1) imt and nhf group, 2) imt and venturi mask group. imt will start as soon as the patient wakes up and is cooperative, ventilated with support settings. each allocated oxygen delivery device will be applied immediately after extubation. imt intervention will continue until patients' discharge from the icu.

Eligibility criteria:
inclusion criteria: * \>65 years, * bmi\> 35kg/m2, * weak cough, * heart (i.e heart failure ) and lung comorbidities (i.e copd), * hypercapnia during mechanical ventilation * \> 72hours on mechanical ventilation * failed first spontaneous breathing trial exclusion criteria: * glasgow coma scale (gcs)\<13, * pre-existing neuromuscular disease or deformity of spinal cord, * terminal disease * hemodynamic instability with \>0.1μg/kg/min noradrenaline * patients of immediately need of non-invasive ventilation after extubation

Keywords: inspiratory muscle training nasal high flow
use of care services by patients with borderline personality disorder

Conditions: Borderline Personality Disorder

Summary: borderline personality disorder (bpd) is characterized by a pervasive pattern of instability and impulsivity. several north american prospective studies support the high level of mental health care utilization in this population. there is little data in other systems of health organization, such as france. furthermore, little is known on the variables associated with the mental health service utilization among bpd patients. the main objective was to compare the utilization of mental health care among bpd patients, to the general population and patients with another personality disorder (pd) and to describe the demographic and clinical factors associated with the group of patients who use the most health care.


Eligibility criteria:
inclusion criteria: * affiliated with the health insurance * inpatient psychiatry exclusion criteria: * patient in forced hospitalization * chronic psychotic disorder, mania or hypomania state, known mental retardation. * patient does not speak or read french
effects of a blueberry enriched diet on the skeletal muscle regenerative process

Conditions: Skeletal Muscle Disorder

Summary: one of the greatest challenges faced by older adults is maintaining physical function and strength with aging. deterioration of skeletal muscle with aging leads to loss of mobility, decreased quality of life, and ultimately loss of independence. skeletal muscle deterioration with aging is multifactorial, with a key factor being impaired skeletal muscle regeneration following damage. muscle regeneration is a multistep process that requires a viable population of skeletal muscle specific progenitor cells (mpcs). mpcs reside in the skeletal muscle in a dormant state until activated by stress or injury cues. upon activation, mpcs divide, commit to the muscle cell lineage, and fuse to form new multinucleated cells or repair damaged muscle cells. in older adults this regenerative process is impaired, which amplifies skeletal muscle deterioration. the investigators demonstrated that the ability of mpcs to divide (proliferate) is reduced, while mpc death is elevated in mpcs from healthy older adults. further, the investigators have demonstrated that impaired nutrient metabolism, cellular inflammation, and oxidative stress are key mechanisms in this age-related disruption of mpc proliferation and overall skeletal muscle health. therapies that improve the regenerative process and nutrient metabolism as well as attenuate oxidative stress and inflammation are necessary to improve overall skeletal muscle health of older adults. blueberries have properties that the investigators hypothesize will improve the proliferative capacity (increase cell division and reduce cell death) of mpcs. additionally, the investigators hypothesize that consumption of blueberries will improve skeletal muscle regeneration in the aging population via improved nutrient metabolism, attenuated cellular inflammation, and reduction of oxidative stress. the hypotheses will be tested using a dietary blueberry intervention. serum from our human subjects \[blueberry enriched diet (bed)-serum\] will be collected and used to treat primary human mpcs. ultimately, the investigators hypothesize that a blueberry enriched diet provides an ideal, natural therapy to improve mpc proliferative capacity, which is necessary to attenuate skeletal muscle deterioration.


Eligibility criteria:
inclusion criteria: * young 21-40 y women * old 65-79 y women exclusion criteria: * known musculoskeletal disease (e.g., rheumatoid arthritis) * movement disorder (e.g., parkinson's disease) or other disorder that might affect skeletal muscle mass, function, or metabolism (e.g. diabetes, cancer) * obese (bmi ≥ 30.0 kg/m2) * long-term treatment with exogenous hormones or other pharmacological interventions -known to or that have the potential to influence muscle mass or function (e.g. glucocorticoids) * antibiotic use within 6 months of intervention